Comparison of Transdermal and Oral Estrogens in Adolescent Girls With Ovarian Failure

November 28, 2016 updated by: Darrell M Wilson, Stanford University

Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure

To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: in whom initiation of estrogen therapy has been recommended due to ovarian failure

  • Outpatients
  • age >=12 years to 17.99 years old

Exclusion Criteria:

  • spontaneous menses
  • significant concurrent medical problem including:
  • Liver function tests (LFTs) 3 times normal
  • clotting disorder
  • ongoing cancer treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Vivelle-Dot
17Beta Estradiol - transdermal
Drug: 17Beta Estradiol - transdermal
Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months
Other Names:
  • Vivelle-Dot
Drug: Progesterone, micronized
Given starting at 18 months
Other Names:
  • Prometrium
ACTIVE_COMPARATOR: Premarin
Conjugated estrogens
Drug: Progesterone, micronized
Given starting at 18 months
Other Names:
  • Prometrium
Drug: Conjugated estrogens
Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months
Other Names:
  • Premarin
ACTIVE_COMPARATOR: Estrace
17beta Estradiol
Drug: Progesterone, micronized
Given starting at 18 months
Other Names:
  • Prometrium
Drug: 17beta Estradiol
Oral pill given daily at increasing doses every 6 months for 18 months.
Other Names:
  • Estrace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estradiol
Time Frame: end of study (up to 2 years)
Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.
end of study (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Darrell M Wilson, Stanford University
  • Study Director: E Kirk Neely, Stanford University
  • Sub-Investigator: Sejal Shah, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (ESTIMATE)

December 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2017

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-10272009-4262

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Failure, Premature

Clinical Trials on 17Beta Estradiol - transdermal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe